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How to Audit the Process-Based QMS
Dennis R. Arter and Cianfrani, Charles A. and John E. (Jack) West
$54.00 USD
This book is intended to help individuals involved in managing and conducting audits to ISO 9001:2000. It focuses on auditing as a management process as well as a key driver of continual improvement within an organization. An excellent resource for internal auditors, it is perfect for novice auditors or those who need a refresher on the fundamentals of auditing. This book can be used as a guide to establishing a new audit program or updating one that has been operational for some time. The authors participated in integrating the process approach into ISO 9001:2000 and thoroughly understand its implications for auditing a QMS.
The three main areas of focus in this book include the basics of process-based auditing, the requirements for establishing and managing an internal quality auditing process, and conducting audits. One of its best features is the section on auditing worksheets, forms, checklists, and questions. Included are useful and adaptable examples from every aspect of auditing such as: developing an audit schedule, planning an audit, writing findings, documenting positive and best practices, writing an audit report, and requesting corrective action. The book contains a comprehensive list of questions that auditors can use when conducting quality audits and features this information as well as other useful forms and documents on the accompanying CD-ROM.
Benefits:
- An extensive appendix offering a list of typical questions for different sector and commodity groups including: medical devices; automotive; telecommunications; service providers; and laboratories.
The Corrective Action Handbook
$19.95 USD
The Corrective Action Handbook will help you make your corrective action process more organized, more efficient, and more productive. It's a terrific guide to corrective action for anyone involved in a corrective action process. The book's basic precepts hold true for any size organization. It can be used by quality managers, ISO 9000 management representatives, production supervisors, production group leaders, customer service managers, quality technicians, or anyone else involved in corrective action. The book includes sample forms that guide you through the corrective action process in a logical and straightforward manner.
About the Author:
Denise E. Robitaille brings years of experience in business and industry to her work in the quality profession. As the principal of Robitaille Associates, she has helped companies in diverse fields such as electronic assembly, cutting-edge biotechnology, machine shops and packaging manufacturers to achieve ISO 9000 registration. Her work also encompasses training and auditing. She is a RAB-certified lead assessor, and ASQ Certified Quality Auditor and senior member of the American Society for Quality. Robitaille is an internationally recognized speaker on a variety of quality topics. She is the author of numerous articles as well as The Preventive Action Handbook and The Management Review Handbook.
Check Out the Companion Book: The Preventive Action Handbook
The Preventive Action Handbook
$19.95 USD
How do we harness the elusive concept of preventive action? People often think of preventive action as the extra thing you do after you've finished corrective action - like an extra coat of sealant. Actually, preventive actions are the initiatives you establish to minimize the number of corrective actions you conduct.
The Preventive Action Handbook is a great guide for defining the process, writing the procedure, establishing criteria, developing plans, and reporting back to management. It will help you benefit from a fundamental management tool that has a direct relationship to your organization's bottom line.
The Preventive Action Handbook will help you make your preventive action process more organized, more efficient, and more productive. The book's basic precepts hold true for any size organization. It can be used by quality managers, ISO 9000 management representatives, production supervisors, production group leaders, customer service managers, quality technicians, or anyone else involved in corrective action.
The book includes sample forms that guide you through the corrective action process in a logical and straightforward manner. The forms may be photocopied. They include:
- Preventive Action Organizer Worksheet
- Matrix of Preventive Actions
- Preventive Action Initiative
- Preventive Action Plan
About the Author:
Denise E. Robitaille brings years of experience in business and industry to her work in the quality profession. As the principal of Robitaille Associates, she has helped companies in diverse fields such as electronic assembly, cutting-edge biotechnology, machine shops and packaging manufacturers to achieve ISO 9000 registration. Her work also encompasses training and auditing. She is a RAB-certified lead assessor, and ASQ Certified Quality Auditor and senior member of the American Society for Quality. Robitaille is an internationally recognized speaker on a variety of quality topics. She is the author of numerous articles as well as The Corrective Action Handbook and The Management Review Handbook, both published by Paton Press.
Check Out the Companion Book: The Corrective Action Handbook
Document Control
Denise E. Robitaille
$19.95 USD
A Simple Guide to Managing Documentation
They're supposed to be useful tools, but whether they're printouts, computer files, flowcharts, or forms, documents can often give more headaches than help. And yet without them, most organizations couldn't function. ISO 9001:2000 and other quality management systems place great emphasis on documents, and for good reason. Documents aren't individual, stand-alone elements of the management process. They're interrelated, formatted in different media, and controlled by various and distinct functions. Keeping critical information current and in the right hands requires more than just signing off on procedures. Document control is essential, but where should you begin?
By reading this book. Inside you'll find clear explanations about the document control process as well as practical solutions for creating, organizing, and maintaining documents, including:
- A discussion of different kinds of documents, including electronic media and QMS requirements
- Identifying and defining responsibility
- Understanding the relationship between documents and records
- Tips for document writers
- Managing and maintaining documents
- Issues of accessibility
- Handling revisions and deviations
- Writing document control procedures
About the Author:
Denise E. Robitaille has helped companies in diverse fields such as electronic assembly, cutting-edge biotechnology, machine shops and packaging manufacturers to achieve ISO 9000 registration. Her work also encompasses training and auditing. She is a RAB-certified lead assessor, and ASQ Certified Quality Auditor and senior member of the American Society for Quality. Robitaille is also a member of the U.S. TAG to ISO/TC 176, the committee responsible for updating the ISO 9000 standard series. She is the author of numerous articles as well as The Corrective Action Handbook, The Preventive Action Handbook, The Management Review Handbook and Root Cause Analysis.
ISO 9000…A Legal Perspective
By Dr. James W. Kolka
$29.95 USD
Your company may have implemented and/or registered its quality system to ISO 9001 or may be planning or required to do so in the next few years. However, is your company prepared to evaluate the quality system it has or is planning to implement to ensure that its system is not going to expose your company to legal liabilities in the future?
While ISO 9001 registration provides a recognized approach to quality system implementation and usage, such a system has both positive and negative impacts. An ISO 9000-based quality management system can be both a terrific defense against the occurrence of incidents that might lead to a liability lawsuit and protection against liability if an incident does occur - or it can introduce indefensible evidence of liability for the incident. Your quality system's ability to serve as defense mechanism that provides real benefits or as documented evidence of liability that will provide no benefits to your company is tied to how effective a system your company implements.
Your company will benefit by understanding how to implement a QMS or to revise its existing system to turn that paper trail into a solid defense against legal liability.
Book Contents
This 200-page book explores ISO 9000 from a legal perspective…
- The origins and structure of ISO 9000
- The interrelationships of the different ISO 9000 quality management standards
- Its growing function in the marketplace in the US… and global economies
- Its growing use in regulated sectors
- Its relationship to product safety
- Its product liability implications
- Its possible impact on corporate legal offices and law firms in the future
About the Author
James W. Kolka JD ,PhD, is an international legal consultant and President of Q-Lex International LLC, Preventive Legal Services, of Atlanta, GA, and Hartford, CT. Q-Lex International LLC provides attorney based Preventive Law consulting and training to organizations concerned about liability exposure and legal, regulatory and statutory requirements concerning quality management systems, FDA's Quality System Regulation, environmental management systems and CE marking EU Directives. Dr. Kolka has written more than 200 articles and five books on liability, EU technical standards, competitiveness issues, ISO 9001 and ISO 14001.
ISO 9000:2000 In a Nutshell, 2nd Edition
By Jeanne Ketola and Kathy Roberts
$24.95 USD
The final version of ISO 9001:2000 has been released and the bestselling guide to the new standard has been completely updated to reflect the changes.
If your organization is currently registered to one of the ISO 9000 standards or plans to be registered in the next few years, this book is a must-read. Based on the year 2000 final release, this book includes:
- Guidance on planning the transition from the 1994 version to the 2000 version
- Information on ISO 9001:2000's new process management approach
- The differences between ISO 9001:1994 and ISO 9001:2000, including an easy-to-use matrix that compares the two
- A complete overview of ISO 9001:2000's new requirements
- Updated questions and answers on some of the most commonly asked questions
- And much more.
Table of Contents
- Introduction to the revised edition
- Understanding the process management approach
- Comparing ISO 9001:1994 to ISO 9001:2000
- Noteworthy changes
- Transition planning
- Answers to common concerns
- Cross-reference matrix
- Appendix
- Index
About the Authors
Authors Jeanne Ketola and Kathy Roberts are active members of the U.S. TAG TO ISO Technical Committee (TC) 176, the body responsible for updating the standard. They present a unique inside view of the standard and cut right to the heart of the changes that matter most.
ISO 9001:2000 Management Responsibility In a Nutshell
By Jeanne Ketola and Kathy Roberts
$24.95 USD
The new ISO 9001:2000 standard REQUIRES active, demonstrable management involvement in your quality management system. Auditors are REQUIRED to determine if management is truly involved and committed to the success of the organization's ISO 9001:2000 effort. This new book from the authors of the best-selling ISO 9000:2000 In a Nutshell clearly and concisely explains everything managers need to know to ensure a successful registration.
Book Includes:
- Management responsibility overview
- Management commitment
- Management representative needs
- Quality policies, planning & objectives
- Management review techniques
- Customer feedback utilization.
About the Authors
Authors Jeanne Ketola and Kathy Roberts were active members of the U.S. TAG TO ISO Technical Committee (TC) 176, the body responsible for updating the standard. They present a unique inside view of the standard and cut right to the heart of the changes that matter most.
The CE Mark, Understanding the Medical Device Directive
By Les Schnoll
$34.95 USD
If your organization manufactures and exports medical devices to the European Union, you need to know about the CE Mark and how the Medical Device Directive will affect your organization in the near future. The European Union's Medical Device Directive, formally known as 93/42/EEC, is one of the EU's most frustrating and difficult-to-decipher mandates. Fortunately, author Les Schnoll has taken the mystery out of the directive for medical device manufacturers. Schnoll walks readers through the directive's numerous classes, articles, annexes and requirements. This book is a must read if you're exporting medical devices to the European Union.
Book Includes
- An overview of the directive
- In-depth analysis of the articles
- A description of the annexes
- Medical device classification
- Essential requirements
- How the requirements apply to you
- Flowcharts to determine your product's class
- Conformity assessment routes
About the Author
Les Schnoll is director of regulated industries for KPMG Quality Registrar. He has more than 25 years' experience in quality assurance/quality control, auditing, regulatory compliance, management and microbiology in medical, pharmaceutical, clinical, industrial and food areas. He is knowledgeable in all aspects of medical device and material, pharmaceutical, food, clinical laboratory and chemical industry objectives. Schnoll is authorized by the Medical Device Agency in the United Kingdom to perform assessments to the Medical Device Directive and the EN 46000 standards.
Management System Basics... TL 9000 Q&A, Quality Management System Requirements and Measurements for
$5.95 USD
Quickly orient yourself and your staff to key facets of TL 9000 Quality Management System Requirements and Measurements. This Management Systems Basics booklet answers all of the important questions raised in understanding and using TL 9000, provided in an easily understood format.
Information in this booklet has been updated to reflect the latest wording of the TL 9000 Handbooks (Release 3.0) and the most current interpretation of the requirements. It is available as a booklet to provide a working document that explains the TL 9000 requirements at a cost and format accessible to a wide audience.
Buy enough copies for each member of your organization.
Questions Answered
- What is the QuEST Forum?
- What is TL 9000?
- Why Is TL 9000 Important?
- What is ISO 9000?
- Why is ISO 9001 important?
- How is "quality" defined?
- What is a quality management system?
- What are the benefits of a QMS
- What are the quality management principles
- What are the five QMS fundamentals?
- Will telecommunications suppliers have to implement TL 9000?
- How is TL 9000 related to ISO 9000?
- How is TL 9000 related to ISO 14001?
- How are TQM and MBNQA related to TL 9000?
- What is the TL 9000 Quality Management System Requirements Handbook?
- How does Release 3.0 of the requirements handbook differ from Release 2.5?
- What is the TL 9000 Quality Management System Measurements Handbook?
- How does Release 3.0 of the measurements handbook differ from Release 2.5?
- What is the MRS?
- What are TPI and TQI?
- What is BEAM and what purpose will it serve?
- What is TL 9000 registration?
- What types of TL 9000 registrations are there?
- What is registration and accreditation?
- Why register to TL 9000?
- Is TL 9000 registration required?
- What are the benefits of TL 9000 registration?
- How do I choose a competent registrar?
- How is a QMS conforming to Release 2.5 updated for Release 3.0?
- Will there be a TL 9000 registration "transition period"?
- How does CSQPsm conformance compare with TL 9000 registration?
- How do I implement a QMS?
- What should an organization do first to achieve TL 9000 conformance?
- Where should emphasis be placed during implementation of TL 9000?
- How much effort will TL 9000 require of telecom companies?
- How much will TL 9000 implementation cost?
- What should be considered in a quality policy?
- What value do advanced auditor training courses have in the US?
- What are the international trade ramifications of TL 9000?
- What does "ISO" mean?
- What is the International Organization for Standardization?
- What is ANSI?
- What are ASQ and the RAB?
- Appendix A: Sources For More Information
- Appendix B: Definitions And Acronyms
Cost: 1-5 copies: $5.95 each; 6-20 copies: $5.45 each; 21-50 copies: $4.95 each; 51-100 copies: $4.45 each; more than 100 copies: $3.95 each
Quality Management Systems, ISO 9000:2000 Q&A
$5.95 USD
Quickly orient yourself and your staff to key facets of ISO 9000:2000 Quality Management System Requirements and Measurements. This Management Systems Basics booklet answers all of the important questions raised in understanding and using ISO 9000:2000, provided in an easily understood format.
It is available as a booklet to provide a working document that explains the ISO 9000:2000 requirements at a cost and format accessible to a wide audience.
Buy enough copies for each member of your organization.
Cost: 1-5 copies: $5.95 each; 6-20 copies: $5.45 each; 21-50 copies: $4.95 each; 51-100 copies: $4.45 each; more than 100 copies: $3.95 each
Management System Basics... ISO 9001:2000 Analysis
$5.95 USD
Here is a subclause-by-subclause analysis of ISO 9001:2000 with reference to relevant guidance and information from ISO 9000:2000 and ISO 9004:2000 on each subclause. This booklet provides a summary of the new requirements in easy-to-understand language for all who are interested in the revised quality management system standards.
This analysis of ISO 9001:2000 is drawn from the three-part series of articles carried in THE INFORMED OUTLOOK newsletter. It has been updated to reflect the final wording of the standard and is being made available as a booklet to provide a working document that explains the new requirements at a cost and format accessible to a wide audience.
Buy enough copies for each member of your organization.
Cost: 1-5 copies: $5.95 each; 6-20 copies: $5.45 each; 21-50 copies: $4.95 each; 51-100 copies: $4.45 each; more than 100 copies: $3.95 each
